BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17150132 · Received June 19, 2023

    Report

    Report Number
    3001421318-2023-02408
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    May 26, 2023
    Report Date
    September 4, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: HAMILTON MEDICAL AG CONSIDERED THIS CER 136079 RISK ID 117 WITH SEVERITY 5 AS A REPORTABLE EVENT AT THE TIME OF THE REPORT. THE TRAINED AND QUALIFIED PARTNER ENGINEER HAMILTON MEDICAL AG ENGINEER PERFORMED THE VOLTAGE MEASUREMENT ON THE INTERACTION PANEL BOARD TEST POINTS. THE SERVICE MANUAL HAMILTON-C6 DESCRIBES HOW TO CHECK THE VOLTAGE MEASUREMENT. THE TEST NEEDS TO BE PERFORMED BY CHECKING THE VOLTAGE ON THE INTERACTION PANEL BOARD TEST POINT N. 17 REFERENCE +28V_IP. THE VALUE OF THE VOLTAGE NEED TO BE IN THE VOLTAGE RANGE FROM 21.00 VOLTS TO 32.00 VOLTS AS DESCRIBED IN THE SERVICE MANUAL HAMILTON-C6. THE MEASUREMENT REPORTED WAS 18 VOLTS AT THE TIME OF THE TEST. THE VOLTAGE MEASUREMENT WAS UNDER THE MINIMUM VOLTAGE. THIS EXPLAINS THE CONDITION OF THE BLACK SCREEN. THE VALUE OF THE VOLTAGE MEASUREMENT NOT IN THE RANGE CAN INDICATE THE VOLTAGE FROM THE MAINBOARD MSP160644 FROM THE VENTILATION UNIT WAS NOT A COMPLAINT. THE MALFUNCTION IS ALSO CONFIRMED BY TESTING THE DEFECTIVE INTERACTION PANEL WITH A DIFFERENT WORKING HAMILTON-C6 WITH NO PROBLEM. THE LOG FILES, ANALYSIS DETERMINED THE FAILURE WAS ON THE MAINBOARD MSP 160644. THE VENTILATOR WAS TAKEN OUT OF SERVICE. THE HAMILTON-C6 MAINBOARD MSP 160644 WAS REPLACED AND CONFIRMED. ALL TECHNICAL SERVICE SOFTWARE CALIBRATIONS AND TESTS HAVE BEEN PERFORMED AND DOCUMENTED WITH NO DEVIATION. THE MAINBOARD MSP 160644 WAS NOT RETURNED YET WITH THE RGA 91097. NO FURTHER ANALYSIS WAS PERFORMED IN THE REPORTING PART. THE VENTILATOR HAS BEEN BROUGHT BACK INTO SERVICE. THE ISSUE IS NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT HAS THE POTENTIAL TO CAUSE SERIOUS INJURY OR DEATH IF IT WERE TO RECUR DURING THE USE WITH A PATIENT. THEREFORE, THE EVENT HAS BEEN DEEMED TO BE A REPORTABLE EVENT. FOLLOWING THE INVESTIGATION, THE INITIAL REPORTABLE EVENT NOW IS CONFIRMED AS A REPORTABLE EVENT NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. HAMILTON MEDICAL AG DEMONSTRATES "GOOD FAITH" IN ANY FAILED ATTEMPTS TO OBTAIN REQUIRED DATA AND "GOOD EFFORT FAITH" TO OBTAIN ADDITIONAL INFORMATION INCLUDING A REQUEST BY E-MAIL TO REQUEST INFORMATION FOR THE REPORTABLE EVENT. SUMMARY: ESM DEFECTIVE, REPLACEMENT OF ESM BOARD.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: THIS IS FROM THE CUSTOMER: I AM WRITING TO YOU BECAUSE I HAVE A SOMEWHAT STRANGE PROBLEM THAT I DO NOT UNDERSTAND. AFTER DOING MY PREVENTIVE MAINTENANCE, I LET THE DEVICE CHARGE (SET IT ASIDE) AND AROUND 1:30 P.M. I UNPLUGGED IT TO GO AND CARRY IT ON ITS UNIT. JUST BEFORE I LEFT MY ROOM, THE C6 TURNED ON BY ITSELF AND I QUICKLY SHUT IT DOWN. THEN I SEE THAT THE STATUS INDICATOR IS ON, AS IF THE DEVICE IS ON, BUT THE SCREEN IS BLACK. THE IGNITION BUTTON WORKS BUT THE REST DOES NOT. I DID A TEST, TOOK THE SCREEN AND PUT IT ON ANOTHER C6 AND THE SCREEN WORKS (IT LIGHTS UP AND I CAN DO MANEUVERS). I TOOK THE SCREEN FROM THE WORKING C6 AND PUT ON THE FAULTY C6 AND THE SCREEN STAYS BLACK. I CONCLUDE THAT THE PROBLEM COMES FROM THE VENTS AND NOT FROM THE SCREEN. I OPENED THE DEVICE AND NOTHING SEEMS DEFECTIVE OR BURNT (A BURNT CHIP) MY QUESTION: HAVE YOU EVER EXPERIENCED THIS AS A PROBLEM OR DO YOU HAVE ANY IDEA WHAT COULD BE CAUSING THIS PROBLEM? (IT IS IMPOSSIBLE FOR ME TO PULL OUT THE LOGS TO SEE WHAT HAPPENED BECAUSE WITHOUT THE SCREEN THAT DOES NOT LIGHT UP I CANNOT PULL THEM OUT). SUMMARY: DISPLAY DISTURBED (REMAINS DARK OR IS FLICKERING).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: THIS IS FROM THE CUSTOMER: I AM WRITING TO YOU BECAUSE I HAVE A SOMEWHAT STRANGE PROBLEM THAT I DO NOT UNDERSTAND. AFTER DOING MY PREVENTIVE MAINTENANCE, I LET THE DEVICE CHARGE (SET IT ASIDE) AND AROUND 1:30 P.M. I UNPLUGGED IT TO GO AND CARRY IT ON ITS UNIT. JUST BEFORE I LEFT MY ROOM, THE C6 TURNED ON BY ITSELF AND I QUICKLY SHUT IT DOWN. THEN I SEE THAT THE STATUS INDICATOR IS ON, AS IF THE DEVICE IS ON, BUT THE SCREEN IS BLACK. THE IGNITION BUTTON WORKS BUT THE REST DOES NOT. I DID A TEST, TOOK THE SCREEN AND PUT IT ON ANOTHER C6 AND THE SCREEN WORKS (IT LIGHTS UP AND I CAN DO MANEUVERS). I TOOK THE SCREEN FROM THE WORKING C6 AND PUT ON THE FAULTY C6 AND THE SCREEN STAYS BLACK. I CONCLUDE THAT THE PROBLEM COMES FROM THE VENTS AND NOT FROM THE SCREEN. I OPENED THE DEVICE AND NOTHING SEEMS DEFECTIVE OR BURNT (A BURNT CHIP) MY QUESTION: HAVE YOU EVER EXPERIENCED THIS AS A PROBLEM OR DO YOU HAVE ANY IDEA WHAT COULD BE CAUSING THIS PROBLEM? (IT IS IMPOSSIBLE FOR ME TO PULL OUT THE LOGS TO SEE WHAT HAPPENED BECAUSE WITHOUT THE SCREEN THAT DOES NOT LIGHT UP I CANNOT PULL THEM OUT). SUMMARY: DISPLAY DISTURBED (REMAINS DARK OR IS FLICKERING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2093592 HAMILTON MEDICAL AG HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown